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FDA NDA · NDA203049

ARGATROBAN

Sponsor: HIKMA PHARM CO LTD

APPLICATION
NDA203049
TYPE
NDA
ORIGINAL APPROVAL
2012-01-05
LATEST ACTION
2026-05-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ARGATROBAN · ReferencePrescription
ARGATROBAN 50MG/50ML (1MG/ML) · INJECTABLE · INJECTION
ARGATROBAN · ReferencePrescription
ARGATROBAN 250MG/2.5ML (100MG/ML) · INJECTABLE · INJECTION

Approval history

2026-05-15Labeling · Supplement 16 · standard — Letter ↗AP
2020-04-22Labeling · Supplement 7 · standard — Label ↗AP
2016-09-30Labeling · Supplement 4 · standard — Letter ↗AP
2016-05-26Labeling · Supplement 5 · standard — Label ↗AP
2014-10-16Manufacturing (CMC) · Supplement 3 · standardAP
2013-02-13Manufacturing (CMC) · Supplement 2 · standardAP
2012-01-05Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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